Cleared Traditional

K961457 - SUBLIMINATOR

K961457 is an FDA 510(k) clearance for SUBLIMINATOR, manufactured by Healex Products, Inc.. The device is a Class 2 Dental device with product code EJI cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K961457 · Healex Products, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
93d
Days
Class 2
Risk

K961457 is an FDA 510(k) clearance for the SUBLIMINATOR. Classified as Syringe, Cartridge (product code EJI), Class II - Special Controls.

Submitted by Healex Products, Inc. (Providence, US). The FDA issued a Cleared decision on July 18, 1996 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6770 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Healex Products, Inc. devices

FDA 510(k) Submission Details - K961457

510(k) Number K961457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1996
Decision Date July 18, 1996
Days to Decision 93 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 127d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJI Device Classification - Class 2, Special Controls

Product Code EJI Syringe, Cartridge
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6770
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EJI Syringe, Cartridge

All 17
Devices cleared under the same product code (EJI) and FDA review panel - the closest regulatory comparables to K961457.
CCS
K983105 · Dentsply Midwest · Mar 1999
GETTIG STYRL-JECT DELIVERY SYSTEM
K972285 · Gettig Pharmaceutical Instrument Co. · Sep 1997
SAFETY INJECTION SYSTEM
K962999 · Integritech, Inc. · Jan 1997
THE WAND
K961648 · Spintech, Inc. · Jul 1996
DENTALOGIC
K960270 · Protecs Syringes International Corp. · Mar 1996
EAGLE
K950309 · Aalba Dent, Inc. · Feb 1995